# K893643: Novametrix MDLS 500A, 505A, 515A, & 7000A Oximeter

- Pathway: 510(k) (Traditional)
- Applicant: Novametrix Medical Systems, Inc.
- Decided: Oct 26, 1989 after 164 days
- Product code: DQA (Oximeter)
- Device class: 2
- Regulation: 21 CFR 870.2700
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K981655: Spacelabs Medical Disposable SP02 Sensor (1999), 0 descendants of its own

## Recalls of this device
- Nov 19, 2009 · Not classified · Z-1307-2010: Power cords' prongs may crack or fail -- Philips was notified that FDA is investigating whether certain types of Electri-Cord Manufacturing Company power cords used with medical devices may be defecti
- Nov 19, 2009 · Not classified · Z-1298-2010: Power cords' prongs may crack or fail -- Philips was notified that FDA is investigating whether certain types of Electri-Cord Manufacturing Company power cords used with medical devices may be defecti
- Nov 19, 2009 · Not classified · Z-1300-2010: Power cords' prongs may crack or fail -- Philips was notified that FDA is investigating whether certain types of Electri-Cord Manufacturing Company power cords used with medical devices may be defecti
- Nov 19, 2009 · Not classified · Z-1301-2010: Power cords' prongs may crack or fail -- Philips was notified that FDA is investigating whether certain types of Electri-Cord Manufacturing Company power cords used with medical devices may be defecti
- Nov 19, 2009 · Not classified · Z-1299-2010: Power cords' prongs may crack or fail -- Philips was notified that FDA is investigating whether certain types of Electri-Cord Manufacturing Company power cords used with medical devices may be defecti
- Nov 19, 2009 · Not classified · Z-1306-2010: Power cords' prongs may crack or fail -- Philips was notified that FDA is investigating whether certain types of Electri-Cord Manufacturing Company power cords used with medical devices may be defecti

Source page: https://510kreport.com/device/K893643
Methodology: https://510kreport.com/methodology